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Clinical Trials/NCT05936684
NCT05936684CompletedNot Applicable

Breathing and Decision-Making: an FMRI Study Investigating the Link Between Slow Breathing and Risky Decision-Making

German Institute of Human Nutrition1 site in 1 country53 target enrollmentStarted: July 4, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
53
Locations
1
Primary Endpoint
Body: Pupil

Study Overview

Brief Summary

The study aims to investigate how slow breathing with prolonged exhalation (i.e., ProlEx breathing) modulates decision-making under risk in healthy participants. To do this, a short-term breathing intervention is combined with a decision-making paradigm while neural, physiological, and behavioral data are recorded.

Detailed Description

This interventional study investigates the modulatory effect of slow breathing with prolonged exhalation (i.e., ProlEx breathing) on decision-making under risk. Using functional magnetic resonance imaging (fMRI), the researchers seek to identify brain regions influenced by the breathing intervention during the decision-making task.

Sixty healthy participants will be invited to perform ProlEx breathing during a risky decision-making task. After initial preparations, each individual's spontaneous breathing rhythm will be determined (i.e., Eupnea, control condition). This step is to i) ensure a natural breathing pace for each participant and ii) incorporate cue-assisted breathing into the control condition to allow comparability across conditions. To further investigate the effect of ProlEx on sympathovagal tone, physiological measures of respiration, electrocardiogram, pulse, electrodermal activity, and pupil are acquired. During scanning, the participant will perform a decision-making task based on the paradigm by Tom et al. (2007). The breathing intervention is applied simultaneously with continuous cue-assisted breathing for both conditions (Eupnea, ProlEx) throughout the duration of the task. The experiment follows a block design with counterbalanced orders to control for confounding effects. After completion of the scans, the participants fill out additional questionnaires.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Healthy men and women
  • •Normal vision (no glasses or contact lenses required)

Exclusion Criteria

  • •Extreme athletes
  • •Extensive lung function (e.g., professional musician, abnoedivers)
  • •Excessive stress
  • •Former or current physical or psychological illness (e.g., lung diseases)
  • •Current or previous medication within 2 weeks before the appointment
  • •Left-handedness
  • •Claustrophobia
  • •Non-removable metal parts or implants inside or on the body (e.g., hip replacements, copper IUD)
  • •Non-removable ferromagnetic objects inside or on the body (e.g., joint replacements)
  • •Non-removable magnetic objects inside or on the body (e.g., artificial eye)
  • •Large tattoos
  • •Young (>18 years) or old (>40 years) subjects
  • •Over- or underweight (BMI <18 or >25 kg/m2)
  • •Pregnancy
  • •Abnormal circadian rhythm (e.g., during shift work)
  • •Excessive alcohol consumption
  • •Illegal drug consumption within 2 weeks before the appointment
  • •Missing consent to participate
  • •Missing consent to receive incidental findings (MRI)

Arms & Interventions

Effect of ProlEx breathing on decision-making if applied before the Eupnea condition

Experimental

Intervention (behavioral): Block 1: ProlEx, Block 2: Eupnea/Control during decision-making

Intervention: Breathing with prolonged exhalation (ProlEx) during risky decision-making (Behavioral)

Effect of ProlEx breathing on decision-making if applied before the Eupnea condition

Experimental

Intervention (behavioral): Block 1: ProlEx, Block 2: Eupnea/Control during decision-making

Intervention: Normal breathing (Eupnea/Control) during risky decision-making (Behavioral)

Effect of Eupnea breathing on decision-making if applied before the ProlEx condition

Experimental

Intervention (behavioral): Block 1: Eupnea/Control, Block 2: ProlEx during decision-making

Intervention: Breathing with prolonged exhalation (ProlEx) during risky decision-making (Behavioral)

Effect of Eupnea breathing on decision-making if applied before the ProlEx condition

Experimental

Intervention (behavioral): Block 1: Eupnea/Control, Block 2: ProlEx during decision-making

Intervention: Normal breathing (Eupnea/Control) during risky decision-making (Behavioral)

Outcomes

Primary Outcomes

Body: Pupil

Time Frame: 1 year

Miosis/mydriasis, i.e., changes in pupil dilation; assessed with eye tracking

Body: Electrodermal activity

Time Frame: 1 year

Tonic electrodermal activity (EDA); assessed using a galvanic skin response module

Behavior: Risk propensity

Time Frame: 1 year

Risk propensity, i.e., the willingness to accept or reject a risky mixed gamble in an adapted paradigm based on Tom et al. (2007); assessed using response options "strongly accept", "weakly accept", "weakly reject", "strongly reject"

Brain: blood-oxygen-level-dependent (BOLD) signal changes

Time Frame: 1 year

BOLD signal changes on a whole-brain level and in predefined regions of interest assessed using fMRI

Body: Heart-rate variability

Time Frame: 1 year

Low-frequency and high-frequency heart rate variability (LF-HRV and HF-HRV, respectively); assessed using an electrocardiogram (ECG) and pulse oximetry

Secondary Outcomes

  • Questionnaire assessing affect: "Positive and Negative Affect Scale" (PANAS)(1 year)
  • Questionnaire assessing self-control: "Brief Self-Control Scale" (BSCS)(1 year)
  • Questionnaire assessing interoceptive awareness: "Multidimensional Assessment of Interoceptive Awareness" (MAIA-2)(1 year)
  • Questionnaire assessing personality traits: "Big Five Inventory" (BFI-10)(1 year)
  • Questionnaire assessing depression: "Beck Depression Inventory" (BDI)(1 year)
  • Questionnaire assessing self-efficacy: "General Self-Efficacy Scale" (GSE)(1 year)
  • Questionnaire assessing impulsivity: "Barratt Impulsivity Scale" (BIS-15)(1 year)
  • Questionnaire assessing approach-avoidance behavior: "Behavioral Inhibition System/Behavioral Approach System" (BIS/BAS)(1 year)
  • Questionnaire assessing stress: "Perceived Stress Questionnaire" (PSQ)(1 year)
  • Questionnaire assessing anxiety: "State-Trait Anxiety Inventory" (STAI-T)(1 year)
  • Questionnaire assessing mentall well-being: "Warwick-Edinburgh Mental Well-Being Scale" (SWEMWBS)(1 year)
  • Body: Eye gaze(1 year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Prof. Dr. Soyoung Q Park

Prof. Dr.

German Institute of Human Nutrition

Study Sites (1)

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